The Compliance Folder format can be either paper or electronic, or a combination of the two. Different countries have different requirements for the contents of the Compliance Folder. Instead of having to obtain formal regulatory approvals, self-declaration schemes mandate that the Compliance Folder must document the product's Regulatory Compliance profile in the areas of Electromagnetic Compatibility (EMC), Safety, and Telecom (if applicable) regulatory compliance. Today, Australia and the European Union mandate the use of a Compliance Folders to validate Self-Declaration. The United States and Canada have also adopted a similar method of Self-Declaration for major computer components.

The most difficult part of the compliance process is developing a consistent approach to the generation of the initial Electronic Compliance Folder. Necessary foresight of how to keep the Compliance Folder up-to-date over the product's life cycle is required, while maintaining backward traceability of any product changes.

What is a Compliance Folder?

Definition: A product's Compliance Folder is a collection of documents that identify and describe the product, provide change history, Regulatory Test Reports, Regulatory Approval Certificates and Declaration(s) of Conformity to prove that a product conforms and continues to conform to the relevant regulatory requirements.

The Compliance Folder must contain the relevant documents that fully substantiate a Declaration of Conformity, which states that the product meets the appropriate and applicable regulatory requirements when examined by an independent Surveillance Authority. At present, the Compliance Folder scheme is always linked to self-declaration regulatory schemes. The product's Life Cycle (change history) must be included in the Regulatory Compliance Folder to document product changes that could or did affect the product's EMC, Safety, and/or Telecom product compliance. By maintaining a Change Control Log within the Compliance Folder, all Engineering Change Orders that could or did affect the products compliance can be tracked. Thus, all product changes and modifications that affect regulatory compliance, and any compliance validation testing, can be included in the product's Compliance Folder.

In self-declaration schemes, it is the manufacturer's responsibility to select the applicable regulatory standards, conduct testing to these requirements, obtain compliant Test Reports, and publish a Declaration of Conformity. All documents that were generated during conformity assessment, including the Declaration of Conformity and all user documentation, are used to create and maintain the Compliance Folder.

Compliance Folder Contents

Australia: The Compliance Folder concept was first initiated in Australia, when the Australian Communications Authority (ACA) first introduced Telecom Compliance by Self-Declaration. This was an entirely new approach to conformity assessment, since it placed the responsibility on the manufacturer to choose the standards to which the product would be assessed, and then to obtain the test reports against the chosen standards. The Australian Communications and Media Authority (ACMA) is now Australia's authority for the A-tick and C-tick regulatory schemes. Once testing is completed and compliant test reports are generated, the registered in-country supplier must then complete and produce the Declaration of Conformity declaring that the product is compliant to the relevant Australian standards. After which, the manufacturer applies the A-Tick Mark (for telecom and radio products) or the C-Tick Mark (for other products) and then places the product on the Market. This new process replaces formal assessment of the Test Reports by the ACMA and does not require the manufacturer to obtain a formal license from the ACMA.

All documents generated during conformity assessment including the Declaration of Conformity and all user documentation are to be included in the Compliance Folder. The ACMA audits the Compliance Folder to ensure that the manufacturer's product is compliant with the relevant standards and the proper testing to verify compliance has been conducted.

Australian Compliance Folder Content Summary

• Original Declaration of Conformity
• A copy of the product's installation and operating instructions
• A set of Regulatory test reports from a recognized testing authority against applicable standards
• Current product model number and related model numbers of the system
• Photograph(s) of the equipment clearly identifying various modules and models that make the complete equipment (if test report(s) does(do) not have it)
• A reference to the version of any software that is incorporated in the customer equipment
• A list of all modular pieces of equipment that can be used with the base item (optional)
• Technical specifications of the item (if manual supplied does not have them)
• Circuit diagram(s) (optional)
• User / Installation Manual which must contain specifications for the correct installation product. If the installation or operation can be configured by the user in a way that will not be compliant with the applicable standards, then a warning must be placed in the User / Installation Manual.

United States - FCC Part 15 EMC

The FCC implemented the Verification and Supplier Declaration of Conformity (SDofC) EMC Emissions schemes for Information Technology and Telecommunications Terminal Equipment to reduce time to market. The manufacturer is responsible for obtaining a compliant Test Report from an FCC Authorized Test Lab prior to declaring the product compliant and applying the FCC Part 15 Label. The compliant EMC Test Report must be made available to the FCC upon request.

• Class A equipment: A compliant verification test report is required for the Compliance Folder. After which, the User / Installation manual needs to have the required statements included and the product needs to have the proper marking statement applied.
• Class B equipment: A compliant certification test report is required for the compliance folder. After which, the User / Installation manual needs to have the required statements included and the product needs to have the FCC label properly applied.

European Union

EMC Directive (2004/108/EC): The "Electromagnetic Compatibility" (EMC) Directive, 2004/108/EC, uses Self-Declaration or Notified Body assessment (for radio products) as the Conformity Assessment routes. Annex IV of this directive provides Technical Documentation requirements to be kept and maintained by the manufacturer.

Low Voltage Directive (2006/95/EC): The Low Voltage Directive, 2006/95/EC, uses Self-Declaration for various types of equipment as the Conformity Assessment route. Annex IV of this directive provides Technical Documentation requirements to be kept and maintained by the manufacturer.

R&TTE Directive (1999/5/EC): The Radio & Telecommunications Terminal Equipment Directive, 1999/5/EC, uses Self-Declaration for Radio Equipment, Satellite Ground Station Equipment and Telecommunications Terminal Equipment as one of the Conformity Assessment routes. Annex II of this directive provides Technical Documentation requirements to be kept and maintained by the manufacturer. However, Notified Body assessment for radio products as the Conformity Assessment route is highly recommended and is accepted in other countries. Any EU Member State's Market Surveillance Authority may ask to review the product's Compliance Folder at any time after the product is placed on the market. If the product is found to be non-compliant by any Market Surveillance Authority, the manufacturer will likely be directed to remedy the non-compliance or remove the product from all EU Member States' markets. The bottom line: if the product is not compliant, the risk of lost revenues could be substantial.

It is the manufacturer's responsibility to generate all necessary and applicable technical documentation and the manufacturer's authorized EU representative must retain a copy of the technical documentation for at least ten years after a product's last manufacture. The manufacturer, or his authorized EU representative, creates a written Declaration of Conformity and then affixes the CE marking to each product. From the European Union's perspective, the Declaration of Conformity is a legal and binding document.

The technical documentation must substantiate the product's conformity to the essential requirements to which it was originally assessed. The technical documentation must cover the design, manufacture and operation of the product to include:

• A general description of the product;
• Conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc.;
• Descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product;
• A list of the standards referred to in the applicable Directive, applied in full or in part, and descriptions and explanations of the solutions adopted to meet the essential requirements of the Directive where such standards have not been applied or do not exist;
• Results of design calculations made, examinations carried out, etc.;
• Test reports.

The manufacturer, or his authorized EU representative, must maintain a copy of the product's Declaration of Conformity with the technical documentation. It is the manufacturer's responsibility to take all measures necessary to ensure that the manufacturing process does not violate or negate the compliance of the manufactured product.

Manufacturing Quality Systems

One of the major problems with maintaining a product's regulatory compliance over the product's life cycle is with inconsistencies within the manufacturing quality system. By documenting the product specific manufacturing requirements, purchasing requirements and floor procedures into a Product Specific Quality Plan, the total product quality and continuation of compliance can be ensured.

The Product Specific Quality Plan can be incorporated into the Compliance Folder to support this essential requirement of the European Union's directives.

Why A Compliance Folder Should Be Generated

Many companies still maintain large paper depositories for product regulatory compliance documentation. However, if the Regulatory Engineer moves to another company or takes a new position, usually the contents of large metal file cabinets become obscure or lost to anyone attempting to extract specific test reports or test certificates for a given product. Thus, the metal file cabinet's role is one of storage of paper documents, however many times the product has fallen out of compliance without anyone realizing what has happened.

Electronic Compliance Folders

Electronic Compliance Folders are the way of the future. Each product or class of similar products should have its own Compliance Folder. By use of hyperlinks, the Compliance Folder can be organized for easy review by any knowledgeable Regulatory Engineer, the engineering manager, or Market Surveillance Authority. Using hyperlinks, any document can be easily located and either viewed on-screen, transmitted electronically to any remote location for on site printing or printed locally.

RPQ Consulting supports the cost effectiveness of scanning all regulatory compliance documents into PDF documents into a maintained database on a hard drive or CD-ROM/DVD-ROM for archival storage. This makes the process of locating a particular document faster, and it can be transmitted electronically to any location in the world immediately for on site printing. As the cost of electronic storage media (hard drives, CD-ROM, DVD-ROM, etc.) continues to plummet, maintaining compliance folders on electronic media becomes extremely cost effective. The payback for investing in a high-speed scanner, CD-ROM/DVD-ROM Burner and associated software is usually less than 2 years. RPQ Consulting can maintain a client's Compliance Folders and all relevant Regulatory and Industry Standards on the same CD-ROM/DVD-ROM.

NOTE: When copied to an internal Intranet Server, the directory structure of the final Compliance Folder on CD-ROM/DVD-ROM needs to be organized so that all of the Compliance Folder's hyperlinks remain pointing to their respective target files.